The EPISOD study is no longer accepting new patients. We have randomized 214 patients with troublesome post-cholecystectomy pain, as planned. Data are being analyzed, and the results will be published in spring/summer 2014. Preliminary review indicates that sphincterotomy is less effective than anticipated (or hoped), so that the collaborating centers are revising their treatment protocols. Non-invasive approaches and medical treatments should be explored.
SOD is a controversial subject, especially in those patients who have little or no objective findings in lab tests and scans, (i.e. SOD type III). Many are referred to tertiary centers for ERCP with manometry, but the published results of manometry-guided sphincterotomy are not optimal, and there are significant risks, with pancreatitis occurring in up to 20% of patients.
The EPISOD study has been designed to study patients with burdensome pain after cholecystectomy. The goal is to see how many (if any) respond to sphincterotomy (as compared to sham treatment), and what their characteristics are (e.g. their pain patterns and presence of other functional or psychiatric disorders).
Patients are screened to show that they have no significant endoscopic, imaging or lab abnormalities, and to have had appropriate trials of medical treatment. After informed consent, they undergo ERCP with biliary and pancreatic manometry. They are then randomized to sphincterotomy or sham (2:1 ratio), regardless of the manometry results. Those randomized to the sphincterotomy arm and who have raised pancreatic sphincter pressures are randomized again to biliary or to biliary and pancreatic sphincterotomy. All subjects get a small temporary pancreatic stent.
Patients, care givers and research coordinators are blinded to the treatment allocation. Success is defined by substantial reduction in pain burden at one year (without any repeat intervention).